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510(k) Data Aggregation

    K Number
    K190339
    Device Name
    Helioseal F Plus
    Manufacturer
    Ivoclar Vivadent, AG
    Date Cleared
    2019-07-29

    (165 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Abbreviated
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K932078
    Why did this record match?
    Device Name :

    Helioseal F Plus

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Helioseal F Plus is used to seal fissures, pits and foramina caeca.

    Device Description

    Helioseal® F Plus is a light-curing, white shaded fissure sealant featuring fluoride release. Helioseal F Plus is supplied in either a syringe or cavifil delivery form. The fissure sealant is composed of dimethacrylates. In the handling technique, the dental professional will clean the enamel surface to be sealed, isolate the working field, conditioning is performed, a thorough rinse and dry to remove the conditioner, before the application of Helioseal F Plus to the tooth surface.

    AI/ML Overview

    This document is a 510(k) premarket notification for a dental device, specifically a pit and fissure sealant. It demonstrates substantial equivalence to a predicate device, rather than providing a performance study proving a device meets specific acceptance criteria as would be typical for an AI/ML medical device.

    Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance, sample sizes, expert involvement, ground truth establishment, and MRMC studies is not applicable to this document.

    The document primarily focuses on demonstrating equivalence through:

    • Comparison to Predicate Device: Detailed comparison of indications for use, contraindications, technology, principles of operation, and physical properties between Helioseal F Plus (subject device) and Helioseal F (predicate device).
    • Bench Testing: Non-clinical performance testing for physical properties (flexural strength, curing depth, light intensity, wavelength for curing, water sorption, water solubility, radio-opacity) in accordance with FDA Guidance and EN ISO 6874:2015.
    • Biocompatibility Testing: Evaluation for cytotoxicity and genotoxicity according to ISO 10993-1, ISO 7405, and ISO 14971.

    The conclusion states that the devices are substantially equivalent, implying that the new device performs similarly to the already legally marketed predicate device. There are no acceptance criteria, in the sense of accuracy/recall/precision metrics for an AI/ML algorithm, or a human reader study, included in this type of submission.

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